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A team of scientist from Quality Assistance in collaboration with Alain Beck from Pierre Fabre, have published a detailed article highlighting the analytical strategies for both N- and O-linked glycan analysis of biotherapeutics using LC/MS. The workflows for glycan analysis on antibodies includes FabRICATOR digestion and study of the Fc/2 fragment for identification of the Fc glycoforms.…
Biosimilars are gaining in popularity as patents of innovator drugs are expiring. The analytical strategies to characterize and assess the similarity between the innovator product and the biosimilar often involve liquid chromatography and mass spectrometry (LC/MS). In a recent paper from the Freie Universität Berlin, Montacir et al. studied Rituximab and follow-on molecules using FabRICATOR digestion, reduction, and…
Oxidation of methionine residues in the Fc region of a therapeutic antibody may affect the binding of the antibody to Protein A and FcRn leading to difficulties in purification or increased clearence in vivo. For the variable regions of the antibody, oxidation may affect antigen binding or lead to increased immunogenicity. For these reasons, the…
Antibodies are important tools in several scientific research areas, and sometimes it is necessary to cleave antibodies to generate antigen binding (Fab) fragments. The Fab fragments can be used within e.g. imaging, removal of effector functions, infection biology, binding studies, and mass spectrometry. In a recently published book (“Bacterial Pathogenesis, Methods and Protocols”, Humana Press,…
Researchers at LFB Biotechnologies have published the first paper using the Genovis SmartEnzyme GingisKHAN. GingisKHAN digests human IgG1 antibodies in the upper hinge, resulting in intact Fab and Fc fragments. The paper published in Journal of Chromatography describes how charge variants of therapeutic antibodies are characterized in a long term stability study using ion exchange chromatography coupled to…
The level of core fucosylation on therapeutic antibodies have major impact on antibody dependent cell cytotoxicity. To study the core fucosylation, Suli Liu and Li Zang at Biogen have published a method using deglycosylation by GlycINATOR, reduction of the antibody and LC-MS analysis. Using this methodology the scientist could quantify the fucosylation within 1 h, including sample…
Genovis has reached a settlement in its patent infringement lawsuit with Promega Corp. and agreed to a royalty bearing, worldwide license to the patents-in-suit. The settlement ends all ongoing patent-infringement claims between the parties and Promega has agreed to a royalty bearing, worldwide license to the patents-in-suit, thereby ending the lawsuit between the parties. The…
The FabULOUS (SpeB) enzyme digests IgG in the hinge region. The FabULOUS Fab kit is designed for digestion and purification of Fab fragments from mouse IgG antibodies. Incubation at optimized reducing conditions generates intact Fab, easily purified with spin columns. Digestion in the hinge with FabULOUS Affinity purification of Fab fragments using the light chain Preparation of Fab…
The Genovis team has together with Alain Beck, Senior Director Antibody Physico-Chemistry at Pierre Fabre, published a review article summarizing all the current publications using FabRICATOR (IdeS) for characterization of therapeutic antibodies and related products. "The specificity and robustness of the IdeS digestion is critical for generating a homogenous pool of fragments. Combined with…
Researchers at the University of Geneva led by Davy Guillarme has used a novel form of HPLC column, based on wide-pore hybrid silica bonded with amide ligand, and developed an HILIC analytical workflow for characterization of biopharmaceuticals. The scientists used FabRICATOR to fragment trastuzumab to subunits and studied the fragments using the new column with HILIC separation.…
Genovis expands the protease portfolio with GingisREX - a new enzyme with unique specificity for arginine residues. The GingisREX protease can be used for peptide mapping, protein sequencing and post-translational modification analysis using mass spectrometry. Press release Read more about GingisREX
New references are out using Genovis enzymes to study antibody glycation, pairing of high-mannose glycans and ADC characterization using CE-MS.